Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, ...
Nelson Labs, a Sotera Health company and a specialist in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, now performs ...
Seoul National University College of Engineering announced that a research team led by Professor Sunghoon Kwon from the Department of Electrical and Computer Engineering, in collaboration with ...
The 14-day turn around time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell ...
Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...